← Back to Search

Cytokine-induced Memory-like NK Cells

Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Saint Louis, MO

Phase 1 & 2

Waitlist Available

Led By Amanda Cashen, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for patients with relapsed or refractory acute myeloid leukemia and myeloid dysplastic syndromes. Doctors will give chemotherapy to patients before giving them an infusion of donor natural killer cells. This is to help stop the growth of cancer cells and keep the patient's immune system from rejecting the donor cells.

See full description

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II)

Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I)

Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort)

Secondary study objectives

Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric)

Duration of Remission (DOR) (Phase I, Phase II, and Pediatric)

Overall Survival (OS) (Phase I, Phase II, and Pediatric)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Phase II (IL-2): Maximum NK cell/number kgExperimental Treatment7 Interventions

The recipient will begin a lymphodepleting preparative regimen of fludarabine and cyclophosphamide on Day -6. The haploidentical donor identified by HLA matching of the immediate family members will undergo non-mobilized large volume (20-L) leukapheresis on Day -1, and the NK cell product will be infused into the recipient on Day 0. Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses.

Group II: Phase I Dose Level 3: Maximum NK cell/number kgExperimental Treatment7 Interventions

* Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. * Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. * CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. * Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Group III: Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK cellsExperimental Treatment7 Interventions

Group IV: Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK cellsExperimental Treatment7 Interventions

Group V: Pediatric Cohort: Maximum NK cell/number kgExperimental Treatment7 Interventions

* Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. * Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1 * CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0 * Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses

Group VI: Lead-in Cohort & Phase II (ALT-803): Maximum NK cell/number kgExperimental Treatment7 Interventions

* Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. * Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1. * CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0. * Subcutaneous ALT-803 will begin approximately 4 hours after the infusion and will continue for a total of 2 doses (Days 0 and 5).

Group VII: DonorsActive Control1 Intervention

-The haploidentical donor identified by HLA matching of the immediate family members (parents, siblings, and children) will undergo non-mobilized leukapheresis on Day -1. Peripheral blood mononuclear cells (PBMCs) will be collected using standard collection techniques.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1830

Cyclophosphamide

2010

Completed Phase 4

~2280